Multiple Myeloma, Multiple Myeloma in Relapse, Neoplasm, Plasma Cell
Conditions
Keywords
Multiple Myeloma, BCMA, prime Chimeric Antigen Receptor T Cell
Brief summary
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Detailed description
There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
Interventions
BIOLOGICALBCMA targeted prime CAR-T cells
BCMA targeted prime CAR-T cell therapy
Sponsors
Chongqing Precision Biotech Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent; 2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. Evidence for cell membrane BCMA expression 4. All genders, ages: 18 to 75 years# 5. The expect time of survive is above 3 months; 6. KPS\>60 7. No serious mental disorders ; 8. Left ventricular ejection fraction ≥50% 9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 10. Sufficient renal function defined by creatinine clearance≤2 x ULN; 11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications; 13\. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion criteria
1. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD 5. The patients treatment by inhibitor of T cell 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events that related to treatment | 2 years | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) |
| The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy | 2 years | The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of clonal plasma cells in bone marrow | 1 years | In vivo (bone marrow) quantity of clonal plasma cells |
| Levels of IL-6 in Serum | 1years | In vivo (Serum) quantity of IL-6 |
| Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood | 2 years | In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry |
| Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma | 2 years | PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored) |
| Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma | 2 years | OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored) |
| Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma | 2 years | DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored) |
| Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood | 2 years | In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR |
Countries
China
Contacts
Primary ContactZhi Yang, PhD
Outcome results
None listed